by Ardeana Hamlin
of The Weekly Staff
BANGOR — The clinical trials conducted at Acadia Clinical Research are a partnership among the pharmaceutical company sponsoring the trial, the patient volunteering for the study, and the staff at Acadia Clinical Research, said owner Gail Baillargeon.
Baillargeon, a certified clinical research professional, founded the business on Hancock Street in 2004 before moving in April of this year to its current location at 792 Stillwater Ave. Facility staff in addition to Baillargeon include a clinic coordinator, a doctor, and a physician’s assistant.
“All trials are looking for the next best treatments,” she said. “We have access to cutting edge therapies not available in other places.”
The clinical trials that the facility conducts, said Deb Harman, clinical coordinator, “are very controlled and already tried in Phase 1 [which tests the drug on 20 to 80 people] and Phase 2 [which tests the drug on 100 to 300 people]. It’s not so scary anymore.”
Pharmaceutical companies the facility works with include Eli Lilly, AstraZenica, Furiex and GlaxoSmithKline, all in the United States; University of Oxford in England; Boehringer-Ingelhein in Germany; Tadeka and MediVector in Japan; and other companies both nationally and internationally.
All of the work done at Acacia Clinical Research is under the scrutiny of a clinical review professional from the pharmaceutical company sponsoring the trial. “This ensures that Acadia staff is following protocols appropriately. One hundred percent of our work is checked,” Baillargeon said.
Currently, Acadia Clinical Research is seeking volunteers for two studies. The first needs volunteers with Type 2 diabetes who use 200-600 units of insulin daily. This study will look at a concentrated insulin that has been around since the 1930s, but has never been studied in clinical trials, Baillargeon said.
The objective is to determine the feasibility of taking the insulin twice per day to give the same blood glucose levels the patient gets by taking insulin six times per day. “We do a lot of diabetes studies,” Baillargeon said.
The second study needs volunteers who have had a heart attack or stroke three to 12 months ago. In this trial a new cholesterol medication will be studied. The objective is to determine if the medication can increase the patient’s “good” or HDL cholesterol. The new drug, Harman said, can be used in addition to statin drugs for cholesterol, or instead of, for those who cannot take statin drugs.
In order to take part in a study, “both inclusive and exclusive criteria must be met,” Harman said. “We want them to know the good, the bad, and the ugly,” Baillargeon said. “We want them to be sure they want to take part.” And to that end the facility staff provide key facts about the study, details about the study, including purpose, duration, required procedures and key contacts. Risks and possible benefits also are discussed in detail. Participants may withdraw from the trial at any time.
Once a volunteer has agreed by signing formal documents to take part in the study, he or she can expect:
• To make regular office visits.
• To have frequent phone consultations with staff members.
• Blood work.
• Physical exams.
• EKGs if the study involves the heart.
• All medications will be provided.
• A typical office visit that lasts approximately one hour.
“Research is a great way for people to take better care of themselves,” Baillergeon said. “More men than women take part in the trials.”
“We are here to take care of whatever they need,” Harman said. “Patients still go to their own doctors. We share all our records [pertaining to that patient] with their doctors.”
Trials last no less than six months or as long as four to seven years, Baillergeon said.
All of the studies are what is known as “double-blind.” Baillargeon and her staff don’t know which patients in the study receive the drug being tested or the placebo, an inactive medication.
The facility doctor oversees patients to make certain they stay healthy with regard to whatever medication they may take, Baillargeon said.
Baillargeon began working in an oncology research department at Eastern Maine Medical Center in 1988. “I worked on a breast cancer prevention trial for high risk women; Tom Brokaw talked about it on the evening news. It made me proud to do work to add to the health of women,” she said.
After that, she worked at the Diabetes Center for six years before she moved to Northeast Cardiology Associates to do work with trials having to do with drug-bearing stents used in cardiac patients.
Eventually, she determined she wanted to do other things, and founding her own clinical research business was the direction she chose.
“Research goes on in all facets of our lives,” Baillargeon said. “It looks for trends and shows how to make improvements in lots of things [including health]. It’s a very rewarding job.”
For information about Acadia Clinical Research or to inquire about taking part in a clinical trial, call the office at 941-9965, email Gail@acadiaclinicalresearch.com or go to acadiaclinicalresearch.com.